Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06815653
PHASE1

Digital Intervention for Psychedelic Preparation (DIPP): Comparing Meditation and Music-Based Programs

Sponsor: University College, London

View on ClinicalTrials.gov

Summary

This randomised controlled feasibility trial evaluates the Digital Intervention for Psychedelic Preparation (DIPP), a novel 21-day self-guided program designed to prepare individuals for psychedelic experiences. Forty healthy volunteers will be randomly assigned to either a meditation-based intervention or a music-based control condition. Both groups will follow identical program structures, with the key distinction being their daily practice focus: meditation or music listening. Following the 21-day preparation period, participants will undergo a supervised 25 mg psilocybin session at University College London. Assessment visits include an in-person follow-up at 2 weeks post-session, followed by online assessments at 3, 6, and 9 months. The primary outcomes include operational feasibility (recruitment rates and participant retention) and intervention adherence (completion rates of DIPP program activities). Secondary outcomes include participant ratings of the platform's feasibility, acceptability, and usability, as well as changes in psychedelic preparedness, the quality of the psychedelic experience, and mental wellbeing over time.

Official title: Digital Intervention for Psychedelic Preparation (DIPP): A Randomised Controlled Feasibility Trial Comparing Meditation and Music-Based Programs in Healthy Volunteers.

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-03-01

Completion Date

2026-12

Last Updated

2025-11-26

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Psilocybin 25mg

Psilocybin PEX010 is an investigational drug provided in capsule form, containing a 25 mg dose of synthetic psilocybin. The product is manufactured under Good Manufacturing Practice (GMP) standards to ensure purity, potency, and consistency. Each participant will receive a single oral dose of 25 mg psilocybin in a hydroxypropyl methylcellulose (HPMC) capsule. The intervention is administered once during the study session, with the effects expected to last approximately 4 to 6 hours.

Locations (1)

University College London

London, United Kingdom